COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL— 510(k) K113660

Name: FDA 510(k) clearance K113660
Creator: U.S. Food and Drug Administration
Published: 2012-05-03

Substantially Equivalent

Cryotherapy Products, Inc.

FDA 510(k) clearance K113660 for COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL, Substantially Equivalent on 2012-05-03. Applicant: Cryotherapy Products, Inc.. Device class: Unclassified.

Clearance details

Applicant: Cryotherapy Products, Inc.
Product code: Code LKX
Device class: Unclassified
Advisory panel: Unknown
Date received: 2011-12-13
Decision date: 2012-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Terrace Davie, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKX

view all

K172358 — Instalief2018-01-10
K072414 — CRYOSTAT2008-04-07
K042564 — HEMOR-RITE CRYOTHERAPHY2005-09-30
K012746 — ICE BATON2001-11-14
K981428 — ANU ICE1998-07-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.